ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International. Drug facts, warnings, and ingredients follow.
Rx Only
Integral Donor Tube (IDT)
Use aseptic technique.
Caution: Do not use unless the solutions are clear.
For further processing, use standard component processing and storage techniques.
Dispose of containers and materials into appropriate biohazardous waste containers following established procedures.
Single use only. Sterile, non-pyrogenic fluid path. Store at Controlled Room Temperature.
USP Definition of “Controlled Room Temperature”
United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD
Definition of Symbols:
Manufacturer
Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606
Made in USA
Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase-II, Gurgaon 122 002, Haryana, India
Import License No.: FF-504-14890
Imported and Distributed in Thailand by:
Fenwal (Thailand) Ltd.
17th Fl. Thanapoom Tower,
1550 New Petchburi Rd., Makasan
Rajthevi, Bangkok 10400
Thailand
07-19-04-580
REV: A
03/2010
FENWAL, BLOOD-PACK, ADSOL and TRANSFER PACK are trademarks of Fenwal, Inc.
© 2010 Fenwal, Inc. All rights reserved.
R4R7641B
6 Units
Fenwal™
TRIPLE BLOOD-PACK™ UNIT CPD/ADSOL™
PL 146
PL 1240
Plastic
Rx only
Triple BLOOD-PACK™ unit consisting of a primary pack containing 63 mL of CPD anticoagulant solution, for collection of 450 mL of blood, one TRANSFER PACK™ containing 100 mL of ADSOL™ solution and one TRANSFER PACK™ without solution. 16 gauge needle.
See accompanying directions for use. Sterile, non-pyrogenic fluid path. Steam sterilized.
Single use only. Do not vent. Do not use if there is any visible evidence of deterioration.
Dispose of container appropriately. Store at Controlled Room Temperature (refer to direction insert).
Unused packs in open foil pouch may be kept 60 days by folding and securing open end of foil pouch, to prevent possible loss of moisture.
Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.
Each 63 mL of CPD solution contains: 1.66 g Sodium citrate (dihydrate), USP, 1.61 g Dextrose (monohydrate), USP, 188 mg Citric acid (anhydrous), USP, 140 mg Monobasic sodium phosphate (monohydrate), USP. Water for Injection USP to 63 mL
Each 100 mL of ADSOL solution contains: 2.20 g Dextrose monohydrate, USP, 900 mg Sodium Chloride, USP, 750 mg Mannitol, USP, 27.0 mg Adenine, USP. Water for Injection USP to 100 mL.
Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606
Made in USA
07-28-04-578 REV: A
Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase-II, Gurgaon 122 002, Haryana, India
Import License No.: FF-504-14890
MRP Rs. 410 (Inclusive of all taxes)
FENWAL, ADSOL, TRANSFER PACK and BLOOD-PACK are trademarks of Fenwal, Inc.
ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)
anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit |
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Labeler - Fenwal, Inc. (794519020) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fenwal International, Inc. | 091164590 | MANUFACTURE(0942-6495) |